Overview
- 9 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-09-29.
At a glance
Inspections
9
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Sep 2017 – 29 Sep 2017 | Biologics | 483 | View 483 → |
| 29 Jul 2015 – 5 Aug 2015 | Biologics | Clean | |
| 16 Jan 2013 | Not recorded | Clean | |
| 16 Jan 2012 | Not recorded | Clean | |
| 27 Jun 2011 | Not recorded | Clean | |
| 29 Jun 2010 | Not recorded | Clean | |
| 5 Jun 2008 | Not recorded | Clean | |
| 27 Jun 2003 | Not recorded | Clean | |
| 20 Sep 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2017
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Elizabeth B Griffin
29 Sep 2017
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Elizabeth B Griffin
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.30(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Mount Auburn Hospital Blood Bank's 1 Form 483
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat